博坊在线_博坊在线(1+

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INTRODUCTION
The 博坊在线 (1+2) Ag/Ab combo rapid test kit is a rapid, qualitative test for the detection of 博坊在线 p24 antigen and antibodies to all isotypes (IgG, IgM and IgA) specific to 博坊在线-1 including subtype-O and/or 博坊在线-2 simultaneously in human serum, plasma or whole blood. The antigens are prepared with proteins to have 博坊在线-1, gp41, gp120 and gp36. For 博坊在线 2, p24 ab & gp36. The 博坊在线 (1+2) Ag/Ab Combo Test kit (3lines) is intended for professional use, only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA or Western Blot test.

PRECAUTION

1.For in vitro diagnostic uses only.

2.Clean up spills thoroughly using an appropriate disinfectant.

3.Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.

4.Do not mix and interchange different specimen.

5.Anticoagulants such as heparin, EDTA and sodium citrate do not affect the test result.

6.Lcteric, lipemic, hemolysed, heat treated and contaminated specimens may give erroneous results.

7.Do not use test kit beyond expiration date.

SUMMARY AND EXPLANATION OF THE TEST
博坊在线 (Human Immunodeficiency Virus) is recognized as the etiologic agent of Acquired immune Deficiency Syndrome (AIDS). The virus is transmitted by sexual contact, exposure to infected blood, certain body fluids or tissues, and from mother to fetus or child during the perinatal period. 博坊在线-1 has been isolated from patients with high potential risk of developing AIDS.
博坊在线-1 appears to be the most common one while 博坊在线-2 is mostly found in patient samples from West African region. Its course is marked by increasing levels of viral replication and the emergence of more virulent viral strains. This process causes the destruction of the immune system. 博坊在线 infection is staged by CD4 cell counts and clinical symptoms. Not all people progress through all “stages” and the time frames may also very greatly from person to person.

PRINCIPLE
The 4th generation 博坊在线(1+2) Ag/Ab Combo Test kit (3lines) contains a membrane strip, which is pre-coated with mouse monoclonal Anti-博坊在线 p24 antibody on test line “2” region with gp36 and test line “1” region with recombinant 博坊在线-1/博坊在线-2 antigens respectively. The mixture of mouse monoclonal anti-博坊在线 p24 antibody and recombinant 博坊在线-1/博坊在线-2 antigen-colloid gold conjugate form a visible lines (1&2) as the antigen-antibody-antigen or antibody-antigen-antibody gold particle complex with high degree of sensitivity and specificity.
The test lines and control line in the result window have been clearly labeled. For line “2” is for 博坊在线 p24 antigen and/or antibodies to 博坊在线-2 and line “2” is for antibodies to 博坊在线-1/博坊在线-2, and “C” for Control line. All the test lines and control line in the result window are not visible before applying any sample. The control line is used for procedural control and should always appear if the test procedure is performed correctly.

MATERIALS SUPPLIED

1.Forty pouched cassettes with desiccant and dropper.

2.Blood diluent in a dropper bottle, stored at 2-8°C.

3.One piece of operating instruction.

MATERIALS NOT PROVIDED BUT REQUIRED

1.Specimen collection container, either plastic or class.

2.Timer.

3.Disposable gloves.

SPECIMENS COLLECTION AND STORAGE
Fingerstick Specimens(Whole Blood )

1.Clean the area to be lanced with an alcohol swab.

2.Squeeze the end of the fingertip and pierce it with a sterile lancet.

3.Wipe away the first drop of blood with sterile gauze or cotton.

4.Use micropipet to obtain about 100ul fresh blood .

Plasma
1.Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2.Separate the plasma by centrifugation.
3.Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.
Serum
1.Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2.Allow the blood to clot.
3.Separate the serum by centrifugation.
4.Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE
Add 1 drop (1 drop = 35µl) of sample (whole blood/serum/plasma) into the sample well. After all samples completely absorbed, add 1 drop of diluent. Observe the result in 5-15 minutes.

QUALITY CONTROL
An internal procedural control is included in the test. Red line will appears in the control region (C).

Packaging Details:
Pouch+Box+Carton packaging
(1) With our company’s Logo
(2) With the natural package
(3) With OEM package
(4) ODM

Rebecca Yan

Product Manager
Span Biotech Ltd.
Tel: +86(755)89589611
Cell Phone:+8618823462100(WhatsApp)
Web: